1. Field of the Invention
This invention relates to a method and composition for preventing and treating diseases, and more particularly, to a method and composition that uses the selective Cox-2 inhibition characteristic of processed Morinda citrifolia to prevent and treat diseases.
2. Background
People are becoming increasingly more conscientious of their long-term health. With a variety of deadly diseases and ailments threatening public health each year, efforts are ongoing to find treatments and medications that treat and prevent disease. In fact, with statistics such as those provided by the American Cancer Society suggesting that as many as 1,268,000 new cancer cases were diagnosed in 2001, there is a heightened awareness in physical wellness and in avoiding terminal debility. Moreover, cancer in particular, is a significant threat because it is the second leading cause of death in the United States. Nevertheless, other diseases such as Alzheimer's, and other degenerative diseases, continue to destroy lives, and ultimately, cause suffering for families.
In recent years, it has been discovered that the ability to selectively inhibit one isoform of the Cyclooxygenase enzyme, which is a naturally occurring enzyme found in humans, may have the effect of treating and preventing a variety of diseases. In order to understand how selective inhibition of the Cyclooxygenase enzyme prevents and treats diseases, it is first necessary to understand the background and inadequacies of ‘non-selective’ drugs, namely nonsteroidal anti-inflammatory drugs, (NSAIDs), and how such inadequacies motivated the use of selective Cox-2 inhibition drugs to prevent and treat diseases.
Non-selective drugs, such as NSAIDs are traditionally used in treating joint pain, muscle pain, and joint swelling. Examples of NSAIDs include ibuprofen, (e.g., Advil®, Motrin®, Nuprin®), naproxen, sulindac, diclofenac, piroxicam, ketoprofen, diflunisal, nabumetone, etodolac, oxaprozin, and indomethacin. Unfortunately, while NSAIDs are effective in reducing inflammation and pain associated with inflammation, they produce a number of adverse side effects. The major side effects relate to the gastrointestinal tract. For example, between ten and fifty-percent of patients being treated with NSAIDs suffer side effects such as diarrhea, heartburn, increased abdominal pain, and upset stomach. A significant percentage of these patients also develop ulcers in the stomach and the upper-gastrointestinal tract, which can lead to internal bleeding and other complications.
The significant numbers of patients taking NSAIDs, and thereby, suffering an increased risk of ulceration in the stomach, motivated an investigation of the mechanisms by which NSAIDs inhibit and prevent inflammation. The findings of this research then led to the discovery that some inflammation-alleviating drugs, specifically Cox-2 selective inhibitors, can actually be used for more than just pain and inflammation alleviation; they can be used to treat and prevent disease. Specifically, researchers found that inflammation in human tissues is related to the conversion of arachidonic acid (a molecule present in the majority of human body cells) into a prostaglandin in the cells of the tissue. The conversion of arachidonic acid to a prostaglandin requires the presence of the enzyme Cyclooxygenase (hereinafter “Cox”). Thus, Cox is the enzyme that produces pain and inflammation. Consequently, NSAIDs, which inhibit Cox, suppress pain. However, in the early 1990's two isoforms of Cox were discovered: Cox-1 and Cox-2. Cox-1 and Cox-2 both catalyze the first two steps in the biosynthesis from arachidonic acid to the prostaglandins. The difference is that Cox-1 is constitutive and Cox-2 appears inducible. Cox-1 presents in nearly all parts of the body at a constant level to produce the prostaglandins to line the stomach, maintain normal renal function, prevent platelet aggregation. On the other hand, Cox-2 is normally absent from the body and induced at infected sites by those factors associated with inflammation such as bacterial polysaccharie and cytokins, interleukin-1, -2 and tumor necrosis factor. Once induced, Cox-2 produces large amounts of prostaglandins, which in turn, lowers the pain threshold, raises the set point of the temperature-regulating center, and causes peripheral vasodilatation with local redness and edema formation. Accordingly, researchers found that selectively inhibiting Cox-2, while avoiding proportional inhibition of Cox-1, not only reduced pain and inflammation, but also allowed the gastrointestinal lining to retain integrity. Cox-2 selective inhibitors are, therefore, great alleviating tools for chronic pain sufferers, such as arthritis sufferers, because Cox-2 selective inhibition drugs can be taken long-term without causing the detrimental effects associated with long-term use of NSAIDs.
Understanding the mechanisms behind Cox-2 selective inhibition drugs has understandably led to numerous breakthroughs in the medical industry. For instance, in addition to its role in inflammation, multiple pieces of evidence suggest that Cox-2 plays an important role in cell proliferation, and accordingly, in cancer cell growth and prevention thereof. Recent research shows that at the organismal level, Cox-2 is induced physiologically during the mitogenic process of wound healing. This is significant because Cox-2 has been found to be over-expressed in many types of pre-malignant and malignant neoplasms in humans and other organisms. That is, Cox-2 over-expression occurs when Cox-2 becomes elevated early in tumor progression. Consequently, inhibition of such Cox-2 over-expression may prevent and treat cancers of the colon, esophagus, skin, lungs, bladder, stomach, breast, head and neck, prostate, pancreas, and well-differentiated hepatocellular carcinomas, where Cox-2 has thus far been found to be over-expressed in the majority of tumors in humans.
In addition, since inflammation may underlie many other chronic and debilitating diseases, such as Alzheimer's, heart disease, osteoporosis and diabetes, one can conclude that Cox-2 inhibitors may play a role in preventing, delaying, or at least slowing the progress of such diseases.
Examples of current products that selectively inhibit Cox-2 are Celecoxib, known as “Celebrex®,” and Rofecoxib, known as “Vioxx®.” These pharmaceutical products are commonly prescribed for arthritis and other chronic pain sufferers. Unfortunately, there are many disadvantages to “Celebrex®” and “Vioxx®.” For instance, these products are only available through prescription. Moreover, they are expensive and not yet approved for pediatric use or use by a pregnant woman during certain periods of fetal development. In fact, even though selective Cox-2 inhibition drugs have been reported to be a “success,” there are doubts about manufacturers' claims that selective Cox-2 inhibition drugs are “safer” than non-selective Cox inhibitors. Some side effects associated with non-selective Cox inhibitors are also found with selective Cox-2 inhibition drugs. More importantly, people using selective Cox-2 inhibition drugs have been shown to have four times the risk of suffering a heart attack than those taking traditional, non-selective NSAIDs. Further, there is always the risk that Cox-2 inhibition drugs will negatively interact with other drugs.
Thus, it would be advantageous to provide a method and composition that results in selective Cox-2 inhibition and makes possible the prevention and treatment for a variety of diseases, such as various cancers, Alzheimer's, neuro-degenerative diseases generally, and a medley of other diseases. Moreover, it would also be advantageous to provide a Cox-2 inhibition composition and method that not only reduces adverse gastrointestinal side effects, but also goes further and minimizes, if not extinguishes altogether, the risk of heart attacks in Cox-2 inhibition drug users. Finally, it would be further advantageous to provide a Cox-2 inhibition drug, which unlike selective Cox-2 inhibition drugs of the prior art, is not expensive, is available over-the-counter, can be used by people of all ages, and can be used by pregnant during the entire gestational period.